NCT02479997

Clinical Application of Dual Sentinel Lymph Node Staining Method in Breast Cancer Patients

Completed Phase 2 Last updated 22 February 2023

What this trial tests

Phase 2 trial testing Indocyanine green in Breast Cancer in 130 participants. Completed in 27 March 2018.

Timeline

31 March 2015

Primary endpoint
8 March 2018

27 March 2018

Quick facts

Lead sponsor	National Cancer Center, Korea
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	other
Enrollment	130
Start date	31 March 2015
Primary completion	8 March 2018
Estimated completion	27 March 2018
Sites	1 location across South Korea

Drugs / interventions tested

• Indocyanine green (INDOCYANINE GREEN) — full drug profile →
• Radioisotope — full drug profile →

Conditions studied

• Breast Cancer — all drugs for Breast Cancer →

Sponsor

National Cancer Center, Korea

Who can join

Adults 20 to 70, female only, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study aimed to compare detection rate between dual sentinel node staining method using mixture of indocyanine green (ICG) with radioisotope(RI), and RI only.

To identify the first lymph node(s) along the lymphatic drainage pathway from the primary tumor in the breast cancer using RI only has several disadvantages such as invisibility, interference. As ICG can be visualized with a fluorescence imaging system, we expects dual sentinel lymph node staining method had better outcomes.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Fluorescence Guidance in Surgical Oncology: Challenges, Opportunities, and Translation.
   Olson MT, Ly QP, Mohs AM. · · 2019 · cited 48× · PMID 29942988 · DOI 10.1007/s11307-018-1239-2